Right Ventricular Function in Patients Taking Carfilzomib | NCT06568952

Studies
Right Ventricular Function in Patients Taking Carfilzomib

NCT06568952

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 23, 2024Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2024Actual

Primary Completion Date

Jun 30, 2024Actual

Completion Date

Jul 30, 2024Actual

First Submitted Date

Aug 20, 2024

First Submission Date that Met QC Criteria

Aug 22, 2024

First Posted Date

Aug 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2024

Last Update Posted Date

Aug 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.

Detailed Description

Patients had a cardiac ultrasound scan prior to the introduction of carfilzomib and an ultrasound scan following the introduction of carfilzomib. We will look at the evolution of right ventricular function parameters in these patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tricuspid annular plane systolic excursion	measurement of tricuspid annular plane systolic excursion by echocardiography	6 months after carfilzomib treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated for multiple myeloma with carfilzomib
Patients with echocardiogram before and under treatment.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with multiple myeloma treated with carfilzomib

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simon Valentin, MD	Université de Lorraine, Département de Pneumologie, CHRU NANCY	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Simon VALENTIN		Nancy		54500	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided